Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma

March 20, 2026 updated by: CoheroHealth

Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma: A Pilot Study

The United Kingdom has a high prevalence of asthma (over 12%) and some of the worst health outcomes in Europe. The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service. With the advancement of digital health technology, there is the potential to transform patient care and improve outcomes.

The Aptar Digital Health respiratory disease management platform, a digital therapeutic will be utilized to determine its value and how it supports: i) asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence; ii) asthma control through the use of the Asthma Control Questionnaire-5. In addition, spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, single comparative study that will accrue a total of 118 participants and compare pre and post study results. Group # 1 will consist of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and ≥ 3 exacerbations / year (biologic eligible). Group # 2 will consist of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and < 3 exacerbations / year (non-biologic eligible). At the baseline visit, clinic appointment # 1, health care providers will review the participants' medical records to determine clinical outcomes in the past year, including number of exacerbations, medication pharmacy refill percentage, and fractioned exhaled nitric oxide score. At the baseline visit, participants will also complete the Asthma Control Questionnaire-5 and the Mini-Asthma Quality of Life Questionnaire. The past year clinical evaluation and Asthma Control Questionnaire-5 and Mini-Asthma Quality of Life Questionnaire will be considered baseline results.

Patients will be screened for study appropriateness at the Guy's Hospital Severe Asthma Clinic. During the initial visit, which will be considered the study baseline visit, patients will be provided with the Aptar Digital Health respiratory disease management platform and trained to use the platform. Participants will be scheduled for in person follow-up visits at 1-2 months and then 6-months post-baseline; patients will be scheduled for virtual visits at 3-months post-baseline.

Patients will then be trained by Guy's Hospital team members; Aptar Digital Health staff will provide extensive training to the Guy's Hospital team prior to the study to ensure the team is fully knowledgeable about the product, its features, and can successfully onboard participants onto the Aptar Digital Health respiratory disease management platform. Once participants are trained, they will utilize the BreatheSmart mobile application by downloading it through either the Apple Store™ or Google Play™.

The BreatheSmart mobile application records, stores, and transmits usage events to the HeroTracker sensors, or via manual user entry, to a remote storage system. Participants may self-enter their medication schedule either with or without the help of their health care providers. Through the BreatheSmart mobile application, they can review information collected from the HeroTracker Sense metered dose inhaler and FindAir ONE dry powder inhaler sensors, report and review their adherence and self-reported symptoms, and answer validated questionnaires.

Participants can share the data entered through the BreatheSmart mobile application with caregivers and health care providers. Health care providers are then able to utilize BreatheSmart Connect, a web application, to obtain an overview of all participants utilizing the Aptar Digital Health respiratory disease management platform including detailed views of individual participant information. Health care providers can view real-time adherence, medication list, participants within and outside of risk zones (depending on adherence), rescue medication usage, symptoms, and triggers. Based on the information gleaned from the BreatheSmart Connect platform, clinicians will schedule follow-up participant appointments with either a junior or senior pharmacist at the Guy's Hospital Severe Asthma Clinic.

Participants will use the Aptar Digital Health respiratory disease management platform for 6 months and will be required to return the device upon study completion.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, SE1 9RT
        • Guy's and St. Thomas' NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

  • Age ≥ 16 years
  • Utilization of asthma controller therapy: inhaled corticosteroids (ICS), long-acting β2-agonists (LABAs) and/or fixed combination therapies of LABA and ICS (medium to high-dose ICS/LABA therapy)
  • Use of metered dose inhaler (MDI) and / or dry powder dose inhaler (DPI) list of compatible controller medications is noted in section 9.2.
  • FeNO ≥ 35 ppb during the baseline assessment.
  • Primary respiratory diagnosis of asthma
  • Uncontrolled, moderate-to-severe asthma. This is defined by an ACQ-5 ≥1.5 during the baseline assessment.
  • Current non-smoker. A 'current non-smoker' has never smoked or has quit smoking for at least 12 months. This is inclusive of all types of smoking: i.e. e-cigarettes/vaping.
  • Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in consent form and protocol.
  • Subject understands and is willing, able, and likely to comply with study procedures and restrictions
  • Willingness to participate in this study and to use the Aptar Digital Health technology
  • Willingness to share information / data with Aptar Digital Health (through informed consent)

Access to technology

  • Access to a smartphone (requirements Android: ≥ 11 or iOS: ≥ 15)
  • Ability to use smartphone (smartphone usability assessment to be provided by Aptar Digital Health)
  • Access to the UK app store or google play store for application download. ● Access to a current email account
  • Access to data / Wi-Fi

Exclusion Criteria

  • Age < 16 years
  • FeNO < 35 ppb
  • Known or suspected alcohol or drug abuse which in opinion of investigator could interfere with subject's proper completion of the protocol requirement
  • History of life-threatening asthma: Defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within last 6 months
  • A lower respiratory tract infection within 7 days of the screening visit ● Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
  • History of hypersensitivity/intolerance to any components of the study inhalers (example, lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
  • Ever received treatment with biological based therapy example, omalizumab, mepolizumab, for asthma.
  • Received an investigational drug and/or medical device within 30 days of entry into this study (Screening), or within five drug half-lives of the investigational drug, whichever is longer
  • An immediate family member of the participating investigator, sub-investigator, study coordinator, employee of the participating investigator, or any family member of a Aptar Pharma, Aptar Digital Health, Voluntis, or Cohero employee.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with fractioned exhaled nitric oxide ≥ 45 ppb
Group 1 consists of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and ≥ 3 exacerbations / year (biologic eligible). Group 2 consists of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and < 3 exacerbations / year (biologic ineligible).
Device: Aptar Digital Health respiratory disease management platform
The Aptar Digital Health respiratory disease management platform is a digital health tool that combines a Healthcare Professional portal (BreatheSmart Connect) and an associated patient mobile application (BreatheSmart mobile application). The Aptar Digital Health respiratory disease management platform is intended to be used in conjunction with compatible connected sensor devices that track medication adherence and for some, technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control Questionnaire - 5 scores
Time Frame: 6 months

Asthma Control Questionnaire - 5 has 5 questions each ranging from a low of 0 to a high of 6. 0 indicates "never" and 6 indicates "always". The minimum mean score is a 0 and the highest mean score is a 6. The lower the score the better the outcome.

Change in normal distribution and mean Asthma Control Questionnaire - 5 scores from baseline to 6 months, which is the end of the study.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Asthma Quality of Life Questionnaire
Time Frame: 6 months

Mini-Asthma Quality of Life Questionnaire has 15 questions each ranging from a low of 1 to a high of 7. 1 indicates "all the time" and 7 indicates "none of the time". The higher the mean score the better the outcome.

Change in normal distribution and mean values of Mini-Asthma Quality of Life Questionnaire scores from baseline to 6-months, which is the end of study.
6 months
Daily controller medication adherence
Time Frame: 6 months
Daily controller medication adherence reported in the Respi.me app (registered as a percentage calculated by number of control doses taken by the participant in relation to the number of scheduled doses)
6 months
Step up to asthma-related biologics
Time Frame: 6 months
Asthma related biologics (step-up from inhaled corticosteroids (ICS) to biologics) scripts and use and associated cost (will be based on biologic utilization for the same type of population noted in published evidence) for those patients who have FeNO ≥ 35 ppb
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma related inpatient hospitalization, associated length of stay, and associated cost
Time Frame: 6 months

Some patients may have asthma related inpatient hospitalizations due to worsening asthma symptoms or exacerbations. If adherence and technique to controller inhaled corticosteroid is improved, there could be less worsening of symptoms and exacerbations and a decrease in inpatient hospitalizations.

The higher the number of inpatient hospitalizations, the worse. The lower the number of inpatient hospitalizations, the better.

Change in inpatient hospitalizations will be noted in the 1-year prior to baseline and then from study start to 6-months, the end of the study.

Change in inpatient hospitalization cost will be determined by multiplying the number of asthma related inpatient hospitalizations between 1-year prior to baseline and then from study start to 6-months by the cost of an inpatient hospitalization.

Cost values will derived either from the NHS costing database or published evidence.
6 months
Computer System Usability Questionnaire
Time Frame: 6 months

The Computer System Usability Questionnaire is a validated questionnaire that is used in digital health to obtain feedback on the usefulness, ease of use, and satisfaction of digital platform.

There are 19 questions in the Computer System Usability Questionnaire. Each question has a range between 1 and 7 with 1 = strongly disagree and 7 = strongly agree. For each question, there is an option for not applicable (NA).

The higher the mean score, the better. The lower the mean score, the worse.

The Computer System Usability Questionnaire will be administered to all patients at the end of the study.
6 months
Semi-structured interviews using the 2019 Rudin et al study
Time Frame: 6 months

The study by Rudin, R.S., Fanta, C.H., Qureshi, N., Duffy, E., Edelen, M.O., Dalal, A.K., Bates, D.W. (2019). A clinically integrated mHealth app and practice model for collecting patient-reported outcomes between visits for asthma patients: implementation and feasibility. App Clin Inform, 10, 783-793 - contains a validated semi-structured interview used to obtain for feedback on the feasibility, acceptability, and use of digital health technologies. Interviews can be administered to patients and health care providers. There are 7 questions for patients. There are 5 questions for health care providers. There is no score as this is a qualitative survey.

Interviews will be conducted either in-person or virtually by the clinical research organization, Lindus Health. At the conclusion of the interviews, Lindus Health will then use thematic analysis will be used to determine the main themes.
6 months
Asthma exacerbations
Time Frame: 6 months
Total patient-reported asthma exacerbations between baseline and month 6.
6 months
FeV1
Time Frame: 6 months

To evaluate the clinical and health economic benefits of using the ADH respiratory platform by comparing utilization between the baseline evaluation and end of study (except for biologics).

The change in FEV1 (forced expiratory volume - 1 second) between baseline and month 6
6 months
FeNO
Time Frame: 6 months

To evaluate the clinical and health economic benefits of using the ADH respiratory platform by comparing utilization between the baseline evaluation and end of study (except for biologics).

The change in FeNO (fractional exhaled nitric oxide) between baseline and month 6
6 months
Asthma related oral corticosteroids utilization and associated costs
Time Frame: 6 months

To evaluate the clinical and health economic benefits of using the ADH respiratory platform by comparing utilization between the baseline evaluation and end of study (except for biologics).

Asthma related oral corticosteroids (OCS) utilization and associated cost iv) Asthma related accident and emergency department visits and associated cost v) Asthma related unscheduled outpatient clinic visits and associated cost vi) Asthma related inpatient hospitalization, associated length of stay, and associated cost
6 months
Asthma related readmissions
Time Frame: 6 months

To evaluate the clinical and health economic benefits of using the ADH respiratory platform by comparing utilization between the baseline evaluation and end of study (except for biologics).

Asthma related readmissions (within 90 days of original inpatient hospitalization), associated length of stay, and associated cost
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CoheroHealth

Collaborators

Lindus Health
Aptar Digital Health

Investigators

  • Principal Investigator: David J Jackson, MRCP MSc PhD, Consultant in Asthma & Eosinophilic Lung Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2024

Primary Completion (Actual)

January 27, 2026

Study Completion (Actual)

January 27, 2026

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADH-BSA-02-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol, SAP, ICF, CSR, and all data analyses will be shared by Aptar Digital Health and Lindus Health (our CRO) with the Guy's and St. Thomas' Hospital Severe Asthma Clinical team. This trial has already been approved by the local Research & Ethics Committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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